Kornimate/medical-research-clean huggingface dataset:
cardioprotective effect of dexmedetomidine in patients with st-segment elevation myocardial infarction

Conditions: ST-segment Elevation Myocardial Infarction (STEMI); Percutaneous Coronary Intervention; Cardioprotection

Summary: this is a double-blind, multicenter, randomized, placebo-controlled clinical trial. it is planned to enroll patients admitted with anterior st-segment elevation myocardial infarction (stemi) within 6h of symptom onset and undergo primary percutaneous coronary intervention (ppci). patients who meet the inclusion criteria and without exclusion criteria were randomized 1:1 into the dexmedetomidine (dex) group or the placebo (saline) group after signing the informed consent. in the dex group, intravenous injection of dex was started immediately after enrollment, covering the entire pci operation, and the administration was stopped at the end of the ppci. the administration of saline was the same as those in the dex group. the primary endpoint was the myocardial infarct size (mis) as assessed by cardiac magnetic resonance imaging (cmr) at 5±2 days post-stemi. based on a superiority design and assuming an 20.0% relative infarct size reduction (from 26.0% to 20.8% with a sd of 13.0%), 250 patients are required to be enrolled, accounting for 20% drop-out (α= 0.05 and power= 80%).


Eligibility criteria:
inclusion criteria: the enrolled subjects must meet all of the following criteria: * aged 18-75 years old (inclusive); * diagnosed with anterior stemi within 6h of symptom onset: (1) ischemic chest discomfort; (2) electrocardiogram (ecg) with st elevation ≥0.2 mv in 2 or more contiguous precordial leads (one of which should be v2, v3, or v4); * sign the informed consent form. exclusion criteria: subjects who meet any one of the following criteria are excluded from the study: * ventricular fibrillation, cardiogenic shock, killip iii-iv grade; * sinus bradycardia (heart rate sustained \ 240ms or ii-iii degree atrioventricular block; * continuous systolic blood pressure \<120mmhg; * severe breathing difficulties, aterial blood oxygen saturation \<92%; * thrombolytic therapy has been performed before the first medical contact in the hospital; * consciousness disorder or past cerebrovascular disease; * previous history of myocardial infarction or pci/cabg treatment; * known severe liver and kidney dysfunction; * known allergy to dexmedetomidine; * cmr contraindications: such as claustrophobia, pacemaker or icd implantation; * pregnant or lactating women; * malignant tumor or expected survival time \<1 year; * any condition which in the opinion of the investigator would make it unsafe or unsuitable for the patient to participate in this study (eg, poor compliance, inability of the patient to comply with study procedures and/or follow up); * participate in other randomized controlled studies at the same time.

Keywords: st-segment elevation myocardial infarction (stemi) percutaneous coronary intervention dexmedetomidine cardioprotection
role of armeo-power and muscle vibration in upper limb rehabilitation

Conditions: Stroke

Summary: muscle vibration (mv) has been suggested as a useful non-pharmacological approach to control spasticity. armeo power® (ap) is a robotic exoskeleton for rehabilitation allowing early rehabilitation treatment. the objective of our study was to determine whether ap training coupled with mv applied on antagonist muscles of the spastic upper limb (ul) can reduce the spasticity of agonist muscles. we enrolled 20 chronic post-stroke patients, who underwent 40 daily sessions of ap training. ten subjects (group-a) received muscle mv (on triceps brachii, deltoid, and supraspinatus), whereas the other 10 (group-b) underwent a sham vibration.


Eligibility criteria:
inclusion criteria: * a first ever supra-tentorial unilateral (left hemisphere) ischemic stroke experienced more than three months before the enrollment; * a deficit of shoulder abductor, arm flexor, and elbow extensor muscles ranging from 2 to 4 on the medical research council scale (mrc); * a spasticity of biceps brachii (bb), pectoralis major (pm), and latissimus dorsi (ld) (namely, spastic agonist muscles) ranging from 1+ to 3 on the modified ashworth scale (mas); * age between 50 and 80 years; and (v) caucasian ethnicity. exclusion criteria: * history of concomitant neurodegenerative diseases or brain surgery; * severe cognitive (mini-mental state examination score \<23 points) or language impairment (boston disability aphasia quotient \<4/5); * severe neglect (catherine bergego scale \>15/30); * systemic, bone, or joint disorders, tumors, changes in either central or peripheral sensitivity as well as visual impairments able to interfere with the aims and methods of the research;.(v) concomitant use of drugs for spasticity; * botulin toxin treatment in the last eight months;.(vii) tms contraindications; * history of psychosis; * limited passive range of motion (shoulder abduction \<60°, elbow extension \<30°, specified by a goniometric assessment).

Keywords: robotic rehabilitation muscle vibration combined approach
a comparison of pharmacodynamics and pharmacokinetics of insulin aspart, biphasic insulin aspart 30, 50 and 70.

Conditions: Type 1 Diabetes

Summary: the hypothesis is that an optimal formulation of fast acting and intermediary acting insulin analogues will improve post prandial glycaemic control in patients with type 1 diabetes. objective: the objective is to describe pharmacodynamic (pd) and pharmacokinetic (pk) profiles of insulin aspart (iasp), biphasic insulin aspart (biasp) 30, 50 and 70 for a period of 12 hours following a standard test meal on four days respectively in subjects with type 1 diabetes.

this trial is a single centre, open-label, randomised 4 period cross-over trial, comparing the pk and pd profiles of iasp, biasp 30, biasp 50 and biasp 70 after a standard test meal in subjects with type 1 diabetes. the profiles will be derived over a 12-hour period after subcutaneous injection in the abdominal region with a single dose of iasp, biasp 30, biasp 50 or biasp 70 at a test meal. the trial consists of a screening period of 4-21 days and 4 treatment visits

Eligibility criteria:
inclusion criteria: 1. informed consent obtained before any trial-related activities. 2. diagnosed type 1 diabetes before the age of 40 and on insulin treatment within one year of diagnosis. 3. insulin treatment of any regime for more than one year at time of inclusion. 4. total insulin demand ≥ 0,5 iu/kg/24 hrs 5. hba1c between 7% and 12 % (both values included). 6. age ≥ 18 years. 7. bmi between 18 and 35 kg /m2 (including both values). exclusion criteria: 1. known or suspected allergy to trial product(s) or related products. 2. recurrent major hypoglycaemic episodes. 3. heart: unstable angina pectoris, ami \< 12 months or heart insufficiency classified according to nyha iii-iv 4. blood pressure: severe uncontrolled hypertension with bp \> 180/110 mmhg, sitting 5. liver: impaired hepatic function corresponding to serum-alat or -basic phosphatase \> 2x upper reference limit of the local laboratory. 6. kidneys: impaired renal function corresponding to serum-creatinin \> 150 μmol/l according to the local laboratory. 7. any disease judged by the investigator to affect the trial. 8. pregnancy, breast feeding or the intention of becoming pregnant or fertile women not using adequate contraceptive measures - adequate contraceptive method is sterilisation, hysterectomy or current use of contraceptive pills or intra uterine device. 9. the receipt of any investigational drug within a three month period prior to this trial.
almond for physical performance

Conditions: Muscle Soreness; Energy

Summary: investigators specific aims are to compare the effects of consuming daily snacks of raw, shelled, unsalted almonds (2.0 ounces) versus an isocaloric amount of another commonly consumed snack food (pretzels) on energy (vigor) perception and physical activity, exercise performance (vo2max and measures of strength), strength and power performance as well as muscle soreness recovery after strenuous eccentrically-biased exercise.

to accomplish these aims, investigators will examine whether regular consumption of almonds versus a common snack food over a period of 8 weeks impacts longer term metabolic, physiological and behavioral responses related to energy sensations and exercise capacity/performance.

Eligibility criteria:
inclusion criteria: * 30-50 years old * bmi of 23-30 exclusion criteria: * smoking, * medications known to impact inflammation, * musculoskeletal limitations and * use of supplements within 1 month of participation that are known to impact antioxidant * use of supplements within 1 month of participation that are known to impact inflammatory status
azd0486 as monotherapy in b-cell acute lymphoblastic leukaemia

Conditions: B-cell Acute Lymphoblastic Leukemia (B-ALL)

Summary: this is a phase 1/2, global multicentre, open-label, single-arm, dose escalation and dose optimisation study of azd0486 to evaluate the safety, tolerability, and efficacy of azd0486 monotherapy in participants with r/r b all who have received ≥ 2 prior lines of therapies. the study will consist of 3 parts. part a monotherapy dose escalation. part b dose optimisation. part c dose expansion at the recommended phase 2 dose (rp2d)

this dose escalation and optimization study is evaluating the safety, tolerability, pk, pd and clinical activity of azd0486 monotherapy in r/r b-all.

Eligibility criteria:
inclusion criteria: * age: 12 years and above (parts a, b and c). * participants with b-cell acute lymphoblastic leukemia with cd19 expression by local lab with: 1. bone marrow infiltration with \>/= 5% blasts 2. either relapsed or refractory after a minimum of 2 prior therapies or after 1 prior line of therapy if no soc available option. 3. philadelphia positive participants are allowed in part a if intolerant or refractory to tkis. * for participants older than 16 years, eastern cooperative oncology group (ecog) performance status less than or equal to 2. for participants 16 years or younger, lansky score more or equal to 50%. the above is a summary, other inclusion criteria details may apply. exclusion criteria: * active cns involvement by b-all, defined by presence of all blasts in csf (cns2 and cns3 criteria). * isolated extramedullary disease relapse. * testicular leukemia * history or presence of clinically relevant cns pathology such as epilepsy, seizure, paresis, aphasia, stroke, severe brain injuries, dementia, parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis; or prior grade 4 neurotoxicity with car-t or tce therapy. * history of other malignancy (with certain exceptions). * unresolved aes \>/= grade 2, from prior therapies * prior therapy with tces within 4 weeks, car t-cell therapy or autologous hsct within 8 weeks or prior allosct within 12 weeks of start of therapy. * gvhd requiring immunosuppressive therapy within 3 weeks prior to azd0486 treatment. the above is a summary, other exclusion criteria details may apply.

Keywords: b-cell acute lymphoblastic leukemia leukemia b-lymphocytes azd0486
study evaluating cariprazine (rgh-188) in the treatment of patients with acute mania

Conditions: Bipolar Disorder

Summary: this is a study designed to evaluate the efficacy, safety, and tolerability of rgh-188 monotherapy in the treatment of acute mania. this study will be 5 weeks in duration; 3 weeks double-blind treatment and 2-weeks safety follow-up. all patients meeting the eligibility criteria will be randomized to one of two treatment groups: rgh-188 or placebo


Eligibility criteria:
inclusion criteria: * male or female inpatients 18 to 65 years of age * meeting diagnostic and statistical manual of mental disorders, fourth edition, text revision (dsm-iv) criteria for bipolar i disorder, acute manic or mixed episode * having a total young mania rating scale (ymrs) score \>= 20 and a score of at least 4 on two of the following ymrs items: * irritability, * speech, * content, and * disruptive/aggressive behavior exclusion criteria: * patients who exhibit abnormalities on physical examination, have abnormal vital-signs, electrocardiogram (ecg), or clinical laboratory values \[such as thyroid-stimulating hormone (tsh)\]. * patients with montgomery-åsberg depression rating scale (madrs) total score \>= 18 at visit 2. * patients experiencing first manic episode. * patients that have received electroconvulsive therapy (ect) or a depot neuroleptic in the 3 months prior to visit 1.

Keywords: mania bipolar i disorder acute mania associated with bipolar i disorder
aripiprazole open-label, safety and tolerability study

Conditions: Schizophrenia; Bipolar Disorder

Summary: the purpose of this study is to test the long-term safety and tolerability of aripiprazole in adolescent patients with schizophrenia, and child and adolescent patients with bipolar i disorder, manic or mixed episode.


Eligibility criteria:
inclusion criteria: * adolescent patients with schizophrenia, or child and adolescent patients with bipolar i disorder, manic or mixed episode exclusion criteria: * patients with a co-morbid serious, uncontrolled systemic illness * patients with a significant risk of committing suicide

Keywords: open label aripiprazole bipolar i disorder, manic or mixed episode
cognitive training in inpatient treatment for substance use disorders

Conditions: Substance Use Disorders

Summary: this study examines whether computer tasks can improve memory and other cognitive functions among patients receiving inpatient treatment for substance use disorders.

participants will complete cognitive training sessions on a regular basis during inpatient treatment. alternate versions of the computer tasks will be compared in a randomized design. primary and secondary outcomes will consist of changes in cognitive performance before and after the training period.

Eligibility criteria:
inclusion criteria: * participants must be patients registered for inpatient treatment at the centre for addiction and mental health * age 18-60 * fluency in english * able to attend scheduled training sessions * comfortable using a computer and mouse exclusion criteria: * severe cognitive impairment * current or past psychosis or diagnosis of schizophrenia * photosensitive epilepsy or history of seizures triggered by light * legal mandate to attend treatment
clinical study evaluating targeted biopsies and cytological imprints in prostate cancer

Conditions: Prostate Cancer

Summary: the investigators will evaluate the accuracy of performing cytological imprints of targeted biopsies when diagnosing prostate cancer. it is useful to know whether the biopsy is cancer or not, in order to know when to stop sampling and when to continue. the strategy is used in other types of cancer, e.g lung, breast etc

background: when substituting a random biopsy procedure with a few targeted biopsies, it is of outmost importance to know immediately if the biopsy is positive or not. a recent study has demonstrated a high sensitivity and specificity of imprint cytology of random biopsies. aim: the correlation between cytological imprints and histology of targeted prostate biopsies material\&method: all patients in this study are already participating in an ongoing randomized biopsy study (nct01455792) comparing: 1. preoperative mri and targeted biopsies + random biopsies . 2. random biopsies (gold standard). only patients with a positive mri were included in this collateral study. the cytological imprints (negative/positive) of each targeted biopsy is compared to the histology (negative/positive) and gleason score.

Eligibility criteria:
inclusion criteria: * prostate specific antigene (psa) 4-20ng/ml, and/or abnormal digital rectal examination * no previous prostate biopsies * positive mri * signed letter of informed concent exclusion criteria: * contraindications to mri * previous prostate biopsies

Keywords: prostate cancer targeted biopsies cytological imprints histology
assessment of intrahepatic hepatitis c virus (hcv) rna levels at the time of liver transplantation

Conditions: Hepatitis C Virus; Liver Transplantation

Summary: the purpose of this study is to measure intrahepatic hcv rna levels at the time of liver transplantation in patients receiving antiviral therapy while on the liver transplant waiting list. this will eventually be correlated with the degree of hepatic fibrosis present within different geographic sites in the cirrhotic liver. tissue samples will be obtained from the patient's liver explant as well as hilar lymph nodes. upon the removal of the cirrhotic liver at the time of transplantation, the explant will be biopsied multiple times in different segments of the liver and preserved for viral detection studies as well as analysis of the degree of fibrosis. peripheral blood mononuclear cells (pbmcs) will be obtained for viral detection at the time of transplantation. serum hcv rna levels will also be obtained at 1 month, 3 months and 6 months post liver transplantation. study hypotheses: * virological relapse or non-response is higher is patients with cirrhosis due to failure of antiviral medication to concentrate adequately in a fibrotic liver having an altered sinusoidal micro-architecture * hcv may persist in different geographic regions of the fibrotic liver in part predicated on blood supply to that area and this may have an effect on overall virological response. these differences in viral persistence and detection may exist in different lobes of the liver or even within a few centimeters within the same portion of the liver parenchyma. * pbmc and hilar lymph nodes may be extrahepatic reservoirs of hcv viral persistence in patients receiving antiviral therapy and may account for virological relapse post-therapy * there may be varying degrees of fibrosis within the same cirrhotic liver which may impact on hepatic synthetic function and antiviral response to treatment.


Eligibility criteria:
inclusion criteria: * patients age 18-80 with chronic hcv on the liver transplant waiting list may be eligible for participation * the following subjects will be enrolled: * patients undergoing liver transplantation who are documented hcv viral load undetectable while on antiviral therapy * patients receiving anti-viral therapy and who have a detectable hcv viral load * patients not currently receiving antiviral therapy and are hcv pcr (+) will be included and serve as a comparison group exclusion criteria: * patients who are co-infected with hiv and/or hbv will not be included

Keywords: hepatitis c virus liver transplantation antiviral therapy hcv
sarcopenia and risk of falls in patients with major chronic diseases

Conditions: Stroke; Osteoporosis; Chronic Kidney Diseases; Cancer

Summary: the objective of this study is to investigate the effects of therapeutic exercise and nutrition intervention for sarcopenia and risk of falls in patients with major chronic diseases. the outcomes will be analyzed regarding muscle strength, quality, and volume, etc., balance and gait, bone density, body composition, fall and quality of life after the intervention.

the main common chronic diseases in the elderly such as stroke, osteoporosis, chronic kidney disease and cancer, have been regarded as the fall high-risk patients. these patients are considered to be at risk for sarcopenia due to decreased exercise, nutritional status, and other reasons. sarcopenia can be diagnosed and intervened effectively to delay the vicious cycle of health. past studies have pointed out that in addition to drug intervention, treatment for sarcopenia must be accompanied by appropriate exercise and nutritional intervention (such as protein supplements, vitamin d) in order to achieve the best prevention and treatment.

Eligibility criteria:
* inclusion criteria: 1. 55-85 years old 2. 3-6 months after onset 3. walk independently for at least 10m * exclusion criteria: 1. lower limb brunnstrom stage \>5 2. combine other neuropathy diseases 3. significant deformity of lower limb include: modified ashworth scale(mas) \>3; contracture, fracture, chronic joint pain. 4. joint arthroplasty 5. unstable vital sign 6. can not cooperate study

Keywords: sarcopenia stroke osteoporosis chronic kidney disease cancer balance and gait fall
impact of transcutaneous auricular vagus nerve stimulation on digestive symptoms in systemic sclerosis systemic sclerosis

Conditions: Systemic Sclerosis

Summary: the purpose of this study is to assess the effect of transcutaneous auricular vagus nerve stimulation (ta-vns) on gastrointestinal symptoms and quality of life in systemic sclerosis (ssc) patients.

conduct of study: entry into the study: after informed consent, patients will be randomised into two arms (active or sham stimulation). the person responsible for setting the stimulator will make the randomization via an interactive web response system (iwrs). only this person will have the knowledge of the group allocated to the patient. start of ta-vns sessions according to the 1st modality of stimulation : the patient will perform 2 stimulation sessions per day at home for 3 months. during this period a clinical research associate will contact the patient to verify that he does not encounter any problems with the stimulator. an evaluation visit will be carried out at the end of these three months by a blind physician. wash-out period during 1 month. start of ta-vns sessions according to the 2nd modality of stimulation : the patient will perform 2 stimulation sessions per day at home for 3 months. an evaluation visit will be conducted prior to the start of the sessions and another at the end of the sessions.

Eligibility criteria:
inclusion criteria: * ssc meeting acr-eular (american college of rheumatology- european league against rheumatism) criteria. * treatment by proton pump inhibitor (ppi) initiated for at least 3 months. * patient's written consent * affiliated with social security system exclusion criteria: * patients who have previously received central or peripheral neurostimulation treatment regardless of indication. * people equipped with an active pacemaker in the area of application of the stimulation electrodes. * people with dermatological disease in the area of application of stimulation electrodes * people with recent venous or arterial thrombosis (less than one month) * people with a cochlear implant near the stimulation site * people followed for proven heart disease * person who are protected under the act * pregnant or breastfeeding woman

Keywords: transcutaneous auricular vagus nerve stimulation digestive symptoms ta-vns